Enteral feeding pump certification

ABSTRACT

A method of performing a certification on an enteral feeding pump based on at least one operating parameter of the pump includes communicating certification information between the pump and a certification application remote from the pump. The at least one operating parameter is compared to a specified operating metric to verify that the at least one operating parameter of the pump is within the specified operating metric.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation application of U.S. patentapplication Ser. No. 14/729,748, filed Jun. 3, 2015, which claims thebenefit under 35 U.S.C. § 119 to U.S. Patent Application No. 62/007,102,filed on Jun. 3, 2014, the complete disclosures of which areincorporated herein by reference for all purposes.

BACKGROUND

The present invention generally relates to a certification system for apump, and more particularly, to a wireless certification system forverifying that certain components of a pump are functioning properly,within a predetermined operational range.

Pumps are frequently used to deliver nutritional and medicinal fluids topatients. It may be important to ensure consistent and accurate deliveryof these fluids for the health and safety of the patient. Accordingly,pumps may be certified on an occasional or more frequent schedule.During certification, components of the pump are tested to verify thatthey are functioning properly, within a predetermined operational range.Prior art certification systems may require an operator to use a specialfeeding set, which requires the operator to retrieve the pump from thefield and perform a manual certification. This method of certificationis costly and interrupts patient use of the pump.

SUMMARY

In one aspect, a method of performing a certification on an enteralfeeding pump based on at least one operating parameter of the pumpgenerally comprises communicating certification information between thepump and a certification application remote from the pump. The at leastone operating parameter is compared to a specified operating metric toverify that the at least one operating parameter of the pump is withinthe specified operating metric.

In some embodiments, plural distinct operating parameters of the pumpare determined.

In certain embodiment, the at least one operating parameter of the pumpis determined during delivery of nutritional liquid to the patient

In some embodiments, the certification information is wirelesslycommunicated between the pump and the certification application.

In certain embodiments, the at least one operating parameter istransmitted to the remote certification application.

In some embodiments, the processor in the pump receives the specifiedoperating metric from the remote certification application and comparesthe at least one operating parameter against the specified operatingmetric.

In certain embodiments, the processor makes a certificationdetermination whether the at least one operating parameter is within thereceived specified operating metric and stores the certificationdetermination in a memory of the pump.

In some embodiments, the certification determination is transmitted fromthe pump to the remote certification application.

In certain embodiments, a manual certification is initiated to determinethe at least one operating parameter. The manual certification comprisesat least one certification step performed manually by a person. The atleast one operating parameter is transmitted to the certificationapplication.

In some embodiments, the certification application identifies thespecified operating metric.

In another aspect, an enteral feeding pump certification systemgenerally comprises an enteral feeding pump for use with a nutritionalliquid feeding set to deliver nutritional liquid through the feedingset. The enteral feeding pump includes a processor configured todetermine at least one operating parameter of the enteral feeding pumpand a transceiver. A certification application is remote from theenteral feeding pump and includes instructions stored on computerreadable medium and a certification application processor configured toexecute the instructions. The certification application is configuredfor communication with the transceiver of the enteral feeding pump forperforming a certification operation of the enteral feeding pump. One ofthe pump processor and the certification application processor isconfigured to compare the at least one operating parameter of theenteral feeding pump to a specified operating metric. One of the pumpprocessor and the certification application processor is furtherconfigured to provide verification that the at least one operatingparameter of the enteral feeding pump is within the specified operatingmetric.

In certain embodiments, a user interface displays information relatingto the certification application and allows user interaction with thecertification application.

In some embodiments, a memory stores information relating to thecertification application.

In certain embodiments, the certification application identifies thespecified operating metric.

In a another aspect, an enteral feeding pump for use with a nutritionalliquid feeding set to deliver nutritional liquid through the feeding setgenerally comprises a housing capable of receiving at least a portion ofthe feeding set. A pumping device is supported by the housing andconfigured to act on the feeding set to produce fluid flow in thefeeding set when the feeding set is received by the housing. A processoris configured to determine at least one operating parameter of theenteral feeding pump. A memory stores the at least one operatingparameter. A transceiver is configured for communication ofcertification information with a certification application remote fromthe enteral feeding pump.

In some embodiments, the processor is configured to determine pluraldistinct operating parameters and the memory is configured to store saidplural distinct operating parameters.

In certain embodiments, the processor is configured to determine the atleast one operating parameter and the memory is configured to store theat least one operating parameter during operation of the enteral feedingpump to supply the nutritional liquid to a patient.

In some embodiments, the transceiver is configured for wirelesscommunication with the remote certification application.

In certain embodiments, the transceiver is configured to transmit the atleast one operating parameter to the remote certification applicationfor evaluation against a specified operating metric.

In some embodiments, the transceiver is configured to receive a signalincluding the specified operating metric from the remote certificationapplication and the processor is configured to evaluate the at least oneoperating parameter against the received specified operating metric.

In certain embodiments, the processor is configured to make acertification determination whether the at least one operating parameteris within the received operating metric and to store the certificationdetermination in the memory.

In some embodiments, the transceiver is configured to transmit thecertification determination to the remote certification application.

In certain embodiments, the processor is configured to send a signalrecommending a full certification procedure be performed on the pump ifthe processor evaluates the at least one operating parameter to beoutside of the specified operating metric.

In some embodiments, the transceiver is configured to transmit the atleast one operating parameter to the remote certification applicationfor evaluation by the remote certification application against aspecified operating metric identified by the remote certificationapplication.

Other objects and features will be in part apparent and in part pointedout hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective of an enteral feeding pump and a fragmentaryportion of a feeding set received on the pump;

FIG. 2 is a perspective of FIG. 1 with a cassette housing of the feedingset removed;

FIG. 3 is the perspective of FIG. 1 with the feeding set removed;

FIG. 4 is a block diagram schematically illustrating the pump;

FIG. 5A is a block diagram schematically illustrating a certificationsystem;

FIG. 5B is a block diagram schematically illustrating another embodimentof a certification system;

FIG. 5C is a block diagram schematically illustrating a module of thecertification system;

FIG. 6A is a flow chart of a remote certification routine;

FIG. 6B if a flow chart of another remote certification routine;

FIG. 7 is an exemplary display generated by a certification applicationof the certification system emulating a display of the pump;

FIG. 8 is an exemplary display generated by the certificationapplication showing a feed and flush data table over a selected periodof time;

FIG. 9 is an exemplary graph generated by the certification applicationillustrating feed and flush data over a period of time; and

FIG. 10 is an exemplary graph generated by the certification applicationillustrating motor current over time.

Corresponding reference characters indicate corresponding partsthroughout the drawings.

DETAILED DESCRIPTION

There is disclosed a method of performing a certification on an enteralfeeding pump based on at least one operating parameter of the pump, themethod comprising communicating certification information between thepump and a certification application remote from the pump; and verifyingthat the at least one operating parameter is within a specifiedoperating metric. Communicating certification information can comprisewirelessly communicating the certification information. In some cases,communicating the certification information comprises receiving the atleast one operating parameter at the certification application, andwherein verifying that the at least one operating parameter is within aspecified operating metric comprises comparing the received at least oneoperating parameter to the specified operating metric. Verifying thatthe at least one operating parameter is within a specified operatingmetric can comprise comparing using a processor in the pump, the atleast one operating parameter to the specified operating metric, andwherein communicating the certification information comprisestransmitting a verification that the compared at least one operatingparameter is within the specified operating metric. In some cases,communicating certification information comprises transmitting the atleast one operating parameter to the certification application. Themethod can further comprise receiving the transmitted at least oneoperating parameter at the certification application remote from thepump. In some cases, verifying that the at least one operating parameteris within a specified operating metric comprises comparing using aprocessor at the certification application the received at least oneoperating parameter to the specified operating metric. Communicatingcertification information can comprise receiving at the pump thespecified operating metric from the certification application, andwherein verifying using a processor in the pump the at least oneoperating parameter against the specified operating metric. The methodcan further comprise delivering nutritional liquid to a patient, whereindetermining the at least one operating parameter of the pump isperformed during delivery of the nutritional liquid to the patient. Themethod can further comprise making a certification determination whetherthe at least one operating parameter is within the received specifiedoperating metric and storing the certification determination in a memoryof the pump. The method can further comprise transmitting thecertification determination from the pump to the remote certificationapplication. In some cases, verifying that the at least one operatingparameter is within a specified operating metric comprises receiving amanual certification instruction to determine the at least one operatingparameter, the manual certification instruction comprising at least onecertification step performed manually by a person. The specifiedoperating metric can be identified by the certification application. Theat least one operating parameter can include a first operating parameterwith a first specified operating metric and a second operating parameterselected from the group consisting of a status of an ultrasonic sensorin the pump, a status of a power button in the pump, a status orposition of a rotor encoder in the pump, and a status of anaccelerometer in the pump, motor current, and ultrasonic sensor voltagewith a corresponding second specified operating metric, and whereinverifying that the at least one operating parameter comprises verifyingusing a processor at the certification application that the firstoperating parameter is within the first operating metric, and verifyingusing a processor in the pump that the second operating parameter iswithin the second operating metric.

There is also disclosed an enteral feeding pump certification systemcomprising an enteral feeding pump for use with a nutritional liquidfeeding set to deliver nutritional liquid through the feeding set, theenteral feeding pump including a processor configured to determine atleast one operating parameter of the enteral feeding pump and atransceiver in operative communication with the processor; and acertification application remote from the enteral feeding pump andconfigured for communication with the transceiver, the certificationapplication including a certification application processor configuredto execute a certification operation. One of the pump processor and thecertification application processor is typically configured to comparethe at least one operating parameter to a specified operating metric.One of the pump processor and the certification application processorcan be further configured to verify that the at least one operatingparameter is within the specified operating metric. In some cases, thecertification application comprises a user interface for displayinginformation relating to the certification application and allowing userinteraction with the certification application. In some cases, thecertification application further comprises a memory for storing atleast one of the instructions and information relating to thecertification application. In some cases, the certification applicationcomprises instructions to identify the specified operating metric.

Referring now to the exemplary embodiment schematically illustrated inFIGS. 1-3, an enteral feeding pump is generally indicated at 1. The pump1 may comprise a housing 3 that is constructed so as to allow anadministration feeding set 5 to be mounted to the housing. The housing 3may comprise a recess 7 (FIG. 3) for receiving a cassette 9 of thefeeding set 5 to load the feeding set on the pump. The administrationfeeding set 5 can comprise tubing indicated generally at 11 thatprovides a fluidic pathway between a bag 12 of nutritional liquid and apatient (FIG. 1). The bag 12 is shown schematically in FIG. 1. Thecassette 9 may mount the tubing 11 for engaging the tubing with the pump1 when the cassette is received in the recess 7. It will be understoodthat the pump and feeding set may have over configurations within thescope of the present invention.

Referring to FIG. 4, a processor 13 may be programmed to controloperation of the pump 1 to deliver nutritional liquid through thefeeding set 5 and to a patient. As will be explained in detail below,the processor 13 is configured to monitor and determine variousparameters and components of the pump 1 during operation of the pump.The processor 13 may be operatively associated with memory 15 forstoring the determined parameters and components. A transceiver 17 maybe operatively associated with the processor 13 for transmitting thedetermined parameters and components to a remote location and/orreceiving information from a remote location facilitating verificationthat the parameters and components of the pump 1 are functioning withina predetermined operational range. Broadly, the predeterminedoperational range may be a specified operating metric of theparameter/component. To this effect, remote certification of the pump 1can be performed.

As used herein, the term “load” means that the tubing 11 is engaged withthe pump 1 so that the administration feeding set 5 is ready foroperation with the pump to deliver fluid to a patient. It will beappreciated that the term “housing”, as used herein, may include manyforms of supporting structures including, without limitation, multi-partstructures and structures that do not enclose or house the workingcomponents of the pump 1.

The pump 1 may include a user interface with a display screen indicatedat 21 on the front of the housing that is capable of displayinginformation about the status and operation of the pump (FIG. 1). Powerbutton 22 can turn the pump 1 on and off. The pump 1 can furthercomprise buttons 23 and light emitting diodes 25 on the housing 3 foruse with the display screen 21 to facilitate exchanging information,such as providing and obtaining information, between the pump 1 and auser. The light emitting diodes 25 may comprise separate red, yellow,and greed LEDs. A buzzer 26 (FIG. 4) may provide an auditory signal forvarious operations of the pump. Various user interfaces for displayinginformation to the user and receiving user input may be implemented. Anyof the various configurations of the user interface can involveutilizing one or more graphical display subcomponents. As an example,the display screen 21 may be a graphical user interface having a touchscreen by which the user can provide the input information. In otherembodiments, the user interface can be a tethered component that can beused to provide input information, provide operating informationpertaining to the flow control apparatus, or both.

Referring to FIGS. 2-4, the pump 1 may include a pump motor 27 (FIG. 4)located in the housing 3. A pump rotor 28 may be mounted on a rotatableshaft 29 and rotated by the motor 27. In one embodiment, the pump rotor28 includes an inner disk 30, an outer disk 31, and preferably aplurality of rollers 32 mounted between the inner and outer disksrotatable about their longitudinal axes relative to the disks. In theexemplarily illustrated embodiment, the pump motor 27, rotatable shaft29 and pump rotor 28 may broadly be considered a pumping device. Therollers 32 may engage the administration feeding set 5 for moving fluidthrough the feeding set for delivery to a patient.

The motor 27 may draw current from a power source (not shown) to turnthe rotor 28. The current draw of the motor 27 may vary with its load.Thus, when a feeding set is loaded on the pump 1, the tubing 11, incompressed engagement with the rotor 28, may increase the load on themotor 27. Preferably, a properly functioning motor 27 will draw aconsistent current under consistent load conditions, e.g., when nofeeding set is loaded.

Pump electronics of the pump 1 may also include identification readers33A, 33B, the display 21, the motor 27, and an ultrasonic sensor 34. Theprocessor 13 in the housing 3 controls the pump electronics and uses thememory 15. A software subsystem 36 is shown schematically separate fromthe memory 15, and includes a flow monitoring system 36A, a setidentification system 36B capable of identifying the type of set mountedon the pump 1, and a certification system 36C, the operations of whichwill be described more fully hereinafter. Other pump electronics caninclude an accelerometer (not shown) for detecting motion of the pump 1.

To detect flow conditions in a downstream portion of the tubing 11, theultrasonic sensor 34 is configured for alignment with the downstreamportion of the tubing 11. In the illustrated embodiment, the sensor 34is positioned in the recess 7 and is adapted to receive the tubing 11therein when the feeding set 5 is loaded on the pump 1. The ultrasonicsensor 34 may be configured to produce a signal representative of thepressure buildup (or fluid flow) in the downstream portion of the tubing11. In combination with the processor 13 and the flow monitoringsubsystem 36A of software subsystem 36, the ultrasonic sensor 34 may beconfigured to alert to an undesirable flow condition in the downstreamportion of the tubing 11.

As shown best in FIG. 2, a mounting member 14 is configured to engage amount 45 of the pump 1 when the feeding set 5 is loaded thereon.Optional readers 33A, 33B disposed on or within the pump 1, may detectthe presence of respective identification members 35A, 35B attached tothe feeding set 5. Preferably, the identification members 35A, 35B maybe configured to be aligned with respective ones of the readers 33A, 33Bwhen the feeding set 5 is loaded on the pump 1. Upon engagement of themounting member 14 to the mount 45, readers 33A, 33B may be capable ofsensing the identification data represented by the number and positionof the identification members 35A, 35B. In combination with theprocessor 13, memory 15, and software subsystem 36, the readers 33A, 33Band the identification members 35A, 35B may identify at least onecharacteristic of the nutritional liquid associated with the feeding set5 loaded on the pump 1. Additionally, they may provide a signalrepresentative of proper alignment when the cassette 9 is properlyloaded into the housing 3. The set identification subsystem 36B allowsthe pump 1 to identify that a certification set has been loaded, and toconfigure itself for operating in a configuration mode.

As discussed above, the pump 1 includes several features that may beused to ensure consistent and accurate delivery of nutritional ormedicinal solutions to patients (e.g., the identification readers 33A,33B, the ultrasonic sensor 34, motor current, power button 22, buttons23, LEDs 25, buzzer 26, accelerometer, etc.). Many of these features, aswell as other features of the pump 1, can be certified on occasion forthe health and safety of the patient to determine whether the pump isfunctioning within a predetermined operational range. It will beunderstood that not all of these features, or other unnamed featurescould be present within the scope of the invention.

During use, the processor 13 can send instructions to monitor thepumping parameters and intermittently, continuously, or continuallyadjust the instantaneous operating flow rate for the pump 1 to achieve atarget feeding rate. For instance, the processor 13 may keep track ofthe volume of feeding fluid delivered to the patient, and the number ofcalories delivered to the patient. Other feeding parameters, such as butnot limited to elapsed time, remaining time, and fat content delivered,may also be monitored and optionally displayed through, for example, theuser interface. The processor 13 may keep track of other flow parametersof the pump 1 as well as parameters of the pump not directly associatedwith fluid flow.

Similar to the pump electronics, a certification of the monitoredpumping parameters (i.e., volume of fluid delivered, number of caloriesdelivered, etc.) can be performed by comparing the monitored pumpingparameters to target pumping parameters to assess whether the targetpumping parameters are being met and/or a prescribed treatment regimenis being followed. Results of the comparison can be stored in the memory15 for review by the clinician. The data can also be stored in thememory 15 for wireless data mining, service modules, and/or assettracking purposes.

Referring to FIG. 5A, a certification system 40 can be used to perform acertification on the pump 1 to verify that certain parameters andcomponents of the pump 1 are functioning within predeterminedoperational ranges. The transceiver 17 is in operative communicationwith the processor 13 for wirelessly transmitting information retrievedby the processor, such as from memory 15, pertaining to variousparameters and components of the pump 1. The transceiver 17 may comprisea ZIGBEE radio mounted on a printed circuit board (not shown) of thepump 1. The components of the ZIGBEE radio are known by a person havingskill in the art and thus will not be described in detail. It should beunderstood that the ZIGBEE radio may be contained within or disposedexternal to pump 1. The transceiver 17 may also be configured forsending a transmission across a wired connection.

ZIGBEE networks based on the IEEE 802.15.4 standard for wirelesspersonal area networks have been used for collecting information from avariety of medical devices in accordance with IEEE 11073 DeviceSpecializations for point-of-care medical device communication. See,e.g., ZIGBEE Wireless Sensor Applications for Health, Wellness andFitness, the ZIGBEE Alliance, March 2009, which is incorporated byreference herein in its entirety. ZIGBEE networks provide the advantageof being dynamically configurable, for example, in “self-healing” meshconfigurations, and operating with low power requirements (enabling, forexample, ZIGBEE transceivers to be integrally coupled to the medicaldevices under battery power). However, transmission ranges betweenindividual ZIGBEE transceivers are generally limited to no more thanseveral hundred feet. The wireless relay network or additional wirelessrelay networks may be organized according to a variety of other wirelesslocal area network (WLAN) or WPAN formats including, for example, WiFiWLANs based on IEEE 802.11 and BLUETOOTH WPANs based on IEEE 802.15.1.

For compliance with HIPAA regulations, the wireless communication ispreferably conducted securely using, for example, encryption, a SecureSocket Layer (SSL) protocol, or a Transport Layer Security (TLS)protocol.

A remote certification application 42 may communicate with the pump 1through the transceiver 17 to receive the pump information transmittedby the transceiver. The certification application 42 can facilitateanalysis of the received information to verify that the parameters andcomponents of the pump 1 are functioning properly, within apredetermined operational range. The certification application 42 maycomprise a remote user interface (RUI) 44 for displaying informationregarding the certification application 42 and allowing user interactionwith the certification application, a certification memory 46 incommunication with the remote user interface for storing informationregarding the certification application, and a certification processor47 for controlling operation of the certification application. A module48 may be in communication with the transceiver 17 of the pump 1 andconfigured to transmit the certification information to a cloud network50, which can transmit the certification information to thecertification application. The cloud network 50 can be accessed by themodule 48 to send updates regarding the certification application 42 andsend data or commands to the pump 1 regarding the certification system40 as well as updates regarding general pump operation.

In another embodiment, the module 48 may be in direct communication withthe certification application 42 (FIG. 5B) for transmitting informationpertaining to the certification application between the pump 1 and thecertification application. The certification system 40 can also includemultiple modules 48 for communicating with multiple devices. Also,multiple pumps 1 can be included in the certification system 40. Thepumps (via the transceivers) and modules can be arranged in a meshnetwork within a patient facility. The pumps and modules could beconfigured to communicate with one another via associated wirelesslinks. The network could be a ZIGBEE mesh network based on IEE 802.15.4.However, the network may be organized according to a variety of otherwireless local area network (WLAN) or WPAN formats including, forexample, WiFi WLANs based on IEEE 802.11 and BLUETOOTH WPANs based onIEEE 802.15.1.

FIG. 5C provides a block diagram illustrating exemplary components ofmodule 48. The module 48 is configured to receive a ZIGBEE radio signalfrom the transceiver 17 and transmit a WiFi or cellular signal to thecertification application 42 or other location (e.g., cloud network 50)for communicating information between the pump 1 and certificationapplication 42. The module 48 includes a first transceiver 60 forwirelessly communicating with transceiver 17 of the pump 1 via anantenna 62 and a second transceiver 64 for wirelessly communicating withthe cloud network 50 via an antenna 66. Each of the transceivers 60, 64is in communication with a data processing circuit 68, which isconfigured to operate under the control of a controller, e.g.,processor, 70 to accept data received by the transceivers 60, 64 andstore the received data in a memory such as buffer element 72. Inaddition, the data processing circuit 68 is further configured toretrieve data from the buffer element 72 under the direction of theprocessor 70, and provide the retrieved data to a selected one of thetransceivers 60, 64 for transmission.

The processor 70 is also preferably in communication with aninput/output circuit 80, which provides signals to one or more displayelements of the module 48, for example, for indicating a start-up orcurrent status of the module 48, including communication or connectionstatus with the certification application 42 or the cloud network 50.Input/output circuit 80 may also be configured to provide signals toindicate an A/C power loss, and or to be responsive to signals providedby one or more input devices provided in proximity to the one or moredisplay elements.

The module 48 may preferably be provided as a small physical enclosurewith an integral power plug and power supply circuit, such that themodule may be directly plugged into and supported by a conventional walloutlet providing commercial A/C power. The module 48 may also preferablyinclude a battery back-up circuit (not shown) to provide uninterruptedpower in the event of A/C power outage of short duration. Batteryback-up may also be advantageous, for example, for using the module 48in an ambulatory mode that enables the patient to move within andpotentially at a distance from a treatment location, for example, with apump 1 that is a portable feeding device. In this configuration, forexample, the pump 1, the transceiver 17, and module 48 may beconveniently carried in a patient-wearable backpack. It will beunderstood that the module can be configured other than described hereinwithin the scope of the present invention.

The certification system 40, through the certification application 42,may be configured to perform various certification protocols on the pump1. For instance, the certification application 42 can perform a remotecertification protocol on the pump 1 to remotely verify that certainparameters and components of the pump 1 are functioning properly, withinpredetermined operational ranges. The parameters of the pump 1 caninclude but are not limited to, the identification readers 33A, 33B, theultrasonic sensor 34, motor current, power button 22, buttons 23, LEDs25, buzzer 26, accelerometer, set presence reading, accuracy, rotorencoder(s), ultrasonic voltage and frequency, other voltages, and fluiddelivery pumping parameters (i.e., volume of fluid delivered, number ofcalories delivered, etc.).

Referring to FIG. 6A, in the remote certification protocol, at 100, thepump 1 determines at least one pump parameter of the pump. The pumpparameter can be determined during operation of the pump 1 to supplynutritional liquid to a patient. At 110, the pump 1 stores the at leastone pump parameter in the memory 15 of the pump. At 120, the pump 1sends the at least one pump parameter to the certification application42. This can be done at predetermined intervals, and/or at the requestof support personnel using the certification application 42. The pumpinformation is sent between the pump 1 and the certification application42 via the wireless communication between the transceiver 17, module 48,and cloud network 50. At 130, the determined pump parameter is stored inthe certification memory 46 of the certification application 42 alongwith a date and time stamp of when the pump parameter was determined. At140, the determined value of the pump parameter is then compared to apredetermined acceptable range/value for the parameter stored in thecertification memory 46. At 150, a certification analysis of the pumpparameter is completed classifying the pump parameter as either passingor failing certification, and at 160, the results of the analysis can bestored in the certification memory 46. The result could also betransmitted back to the pump 1. In this instance, the comparison of thepump parameters and components is performed by the certificationapplication 42.

Referring to FIG. 6B, the comparison of the pump parameters andcomponents can also be performed by the processor 13 of the pump 1. Ifthe comparison is performed by the processor 13, at 200, the pump 1determines at least one pump parameter of the pump. The pump parametercan be determined during operation of the pump 1 to supply nutritionalliquid to a patient. At 210, the pump 1 stores the at least one pumpparameter in the memory 15 of the pump. At 220, the certificationapplication 42 sends the predetermined acceptable range/value of thepump parameter to the processor 13 via the module 48, cloud network 50,and transceiver 17, and, at 230, the processor uses the receivedrange/value to perform the comparison. At 240, a certification analysisof the pump parameter is completed by the processor 13. At 250, theresults of the analysis can be sent to the certification application 42,and at 260, the results can be stored in the certification memory 46.The certification results can also be stored in the memory 15 of thepump 1.

Whether the comparison is performed by the certification application 42or the processor 13 of the pump 1, the certification system 40 completesa remote certification test on the pump 1 by communicating the pump withthe certification application during the certification routine.Moreover, the certification test is performed without replacing theadministration feeding set 5 with a certification feeding set. Thisallows certification to be performed on the pump 1 wherever the pump iscurrently in use in the field so that support personnel do not have toretrieve the pump from the field, which interferes with patienttreatment. In addition, because the pump 1 stores the determined pumpparameters and components in the memory 15, and the memory is incommunication with the certification application 42, a certificationroutine can be performed at any time. This effectively creates a“continuous certification” feature whereby certification can beperformed on demand. The “continuous certification” feature also permitsthe pump 1 to assess a certification status for a certain pump parameterand instruct a user to initiate a full certification procedure if theassessed certification status it outside of a specified operating metricfor the pump parameter. In some cases, at least one processor isconfigured to send a signal recommending performing certification oneach of the at least one operating parameter if the processor evaluatesthat at least one operating parameter is outside of the specifiedoperating metric.

If the certification system 40 determines that at least one or all thecompared parameters and components are within the predeterminedacceptable ranges, the certification application 42 can identify whichof the parameters and components passed certification. A certificationpage (i.e. a text display) showing the pump certification can bedisplayed on the remote user interface for printing and/or saving to thecertification memory 46. The certification page can include a serialnumber of the pump for recording the certification in association withthe particular pump. A certification date can also be saved in thecertification memory 46.

The remote certification protocol can operate in parallel with variousoperational modes of the certification system 40. During a monitor mode,the certification system 40 provides a real time wireless connectionbetween the certification application 42 and the pump 1 so that supportpersonnel using the certification application may remotely connect tothe pump for at least one of diagnostic, troubleshooting, and trainingpurposes. The remote user interface 44 may also display an emulation ofwhat is being displayed on the display screen 21 of the pump 1. Anexample of the remote user interface 44 displaying an emulation of thepump display screen 21 is shown in FIG. 7. The remote user interface 44replicates the pump display screen 21 showing the most recent datareceived from the pump 1. During diagnostic and troubleshootingoperational modes of the certification system 40, the pump 1 updates thecertification application with typical use and diagnostic use parametersand components periodically and/or upon request from support personnel.Using the remote user interface 44, a support personnel user may graphthe parameters and components to ascertain a level of the pump'sperformance within predetermined ranges (i.e., verify pumpcertification). In one instance, updating the certification application42 with typical use data may include sending information from the pump 1to the certification application regarding the amount of fluid deliveredto a patient. FIG. 8 illustrates an exemplary display of the remote userinterface 44 showing a feed and flush data table over a selected periodof time. FIG. 9 illustrates an exemplary feed and flush graph that canbe displayed on the remote user interface 44. The remote user interface44 may also generate a message reporting the data sent from the pump 1.

FIG. 10 shows a graph of motor current over time, which can be displayedon the remote user, interface 44 during a diagnostic assessment. Graphsand charts may be generated for any diagnostic parameter for a giventime and date. The graphs and charts may also be exported for use inother database applications. Messages regarding troubleshooting may beinitiated upon request of support personnel and may transmit data every15 seconds for 10 minutes to assess a particular problem area of thepump 1. Other time intervals may also be used. When support personnelinitiate a retrieve pump data now request, the pump 1 sends any statusand diagnostic messages reporting the pump data that are available atthe time of the request. This data request can be performed during themonitor mode. Messages regarding software upgrades may be transmittedalong with any scheduled or requested transmission. All messages,notifications, tables, and graphs can be saved in the certificationmemory 46 of the certification application 42.

The certification application 42 may also store cellular numbers in thecertification memory 46 and transmit status and error messages to aselected cellular phone via the module 48.

The certification system 40 can also perform a manual certificationprotocol where a user or support personnel manually operates the pump 1to conduct the certification. The manual certification protocol can beinitiated at the pump 1 or at the remote user interface 44 by sending acommand to the transceiver 17 instructing the pump to perform thecertification functions for obtaining values of certain pump parametersand components. However, a user must manually operate the pump throughthis process. The obtained pump parameters and components can betransmitted to the certification memory 46 of the certificationapplication 42 along with a date and time stamp. The comparison of thepump parameters and components can be performed by the processor 13 ofthe pump or by the certification application 42. If the comparison isperformed by the processor 13, the results can be sent to thecertification application 42 and stored in the certification memory 46.The manual certification protocol can also be initiated in response to adetermination by one of the processor 13 or certification application 42that a determined pump parameter is outside of the predeterminedacceptable range/value for the pump parameter. A certification date canbe saved in the certification memory 46. If a manual certification isinitiated and the certification system 40 determines that sufficientdata for the pump parameters and components is already stored in one ofthe memory 15 of the pump 1 or the certification memory 46, the systemcan initiate a certification protocol without running the pump throughthe manual certification routine.

The certification system 40 can also perform a factory certificationprotocol (broadly, an initial certification) where, after manufacturing,a user logs into the remote user interface 44 and sends a pump serialnumber for a pump to the remote user interface to link the pump with thecertification application 42. The serial number is then stored in thecertification memory 46 and a manual certification as previouslyexplained is conducted. The factory certification protocol can be usedto load initial acceptable ranges and values for certain parameters andcomponents of the pump for use during subsequent certificationprotocols. A date of the factory certification can be stored in thecertification memory 46. Additionally, when the pump 1 is powered on,the certification application 42 can recognize the pump by the serialnumber and identify the pump as active for certification purposes. To doso, a user enters the pump serial number into the remote user interface44 and the serial number is checked against known serial numbers storedin the certification memory 46, such as the serial numbers stored duringthe factory certification. The connection between the pump 1 andcertification application 42 are indicated as valid if the pump serialnumber can be found in the certification memory.

In some configurations, if a user of the remote application attempts toobtain a pump certification determination, the remote application looksback at data gathered over a predetermined past period, e.g., over thelast 10 days, from the pump. For each parameter, the remote applicationwill look at the most recent point gathered in that time; if the lastvalue was out of range, the parameter will fail but if the last valuewas a pass, the parameter will pass. If the remote application has nodata for that parameter over the period, e.g., the last 10 days, theparameter will be indeterminate (unknown). Indeterminate results aretypically caused by the pump not being actively used. Manualcertifications are typically required only if the result of one or moreparameters as stored in the remote certification is failed orindeterminate.

It is to be understood that in the described embodiment, the softwaresubsystem 36, the processor 13, memory 15, and the certificationapplication 42 may be broadly considered “a control circuit”. Thesecomponents may also be individually considered “a control circuit”.Moreover, other types of control circuits may be used within the scopeof the present invention.

The memory 15 and certification memory 46 can comprise one or morenon-volatile memory components, e.g., ROM, PROM, EPROM, EEPROM, andflash memory. In other configurations, other types of non-volatilememory components can be utilized in addition to or instead of thenon-volatile memory components such as but not limited to removable orportable data storage devices, such as hard disk drives, optical disk,magnetic tape, holographic memory, and memory cards. Alternatively or inaddition, memory 15 and certification memory 46 can comprise one or morevolatile memory components such as but not limited to random accessmemory (RAM), dynamic random access memory (DRAM), and static randomaccess memory (SRAM).

Embodiments of the invention may be described in the general context ofcomputer-executable instructions, such as program modules, executed byone or more computers or other devices. The computer-executableinstructions may be organized into one or more computer-executablecomponents or modules including, but not limited to, routines, programs,objects, components, and data structures that perform particular tasksor implement particular abstract data types. Aspects of the inventionmay be implemented with any number and organization of such componentsor modules. For example, aspects of the invention are not limited to thespecific computer-executable instructions or the specific components ormodules illustrated in the figures and described herein. Otherembodiments of the invention may include different computer-executableinstructions or components having more or less functionality thanillustrated and described.

Further, the order of execution or performance of the operations inembodiments of the invention illustrated and described herein is notessential, unless otherwise specified. That is, the operations may beperformed in any order, unless otherwise specified, and embodiments ofthe invention may include additional or fewer operations than thosedisclosed herein. For example, it is contemplated that executing orperforming a particular operation before, contemporaneously with, orafter another operation is within the scope of aspects of the invention.

In operation, the processor 15, certification processor 47, and moduleprocessor 70 execute computer-executable instructions such as thoseillustrated in the figures to implement aspects of the invention.Aspects of the invention may also be practiced in distributed computingenvironments where tasks are performed by remote processing deviceslinked through a communications network. In a distributed computingenvironment, program modules may be located in both local and remotecomputer storage medium including memory storage devices.

When introducing elements of the present invention or the preferredembodiments(s) thereof, the articles “a”, “an”, “the” and “said” areintended to mean that there are one or more of the elements. The terms“comprising”, “including” and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements.

In view of the above, it will be seen that the several objects of theinvention are achieved and other advantageous results attained.

As various changes could be made in the above constructions and methodswithout departing from the scope of the invention, it is intended thatall matter contained in the above description and shown in theaccompanying drawings shall be interpreted as illustrative and not in alimiting sense.

What is claimed is:
 1. A method of performing a certification on anenteral feeding pump based on at least one operating parameter of thepump, the method comprising: communicating certification informationbetween the pump and a certification application remote from the pump;verifying that the at least one operating parameter is within aspecified operating metric indicating that the at least one operatingparameter is functioning properly, wherein verifying that the at leastone operating parameter is within a specified operating metric isperformed during delivery of the nutritional liquid to a patient.
 2. Themethod of claim 1, wherein communicating certification informationcomprises wirelessly communicating the certification information.
 3. Themethod of claim 2, wherein communicating certification informationcomprises transmitting the at least one operating parameter to thecertification application.
 4. The method of claim 3, further comprisingreceiving the transmitted at least one operating parameter at thecertification application remote from the pump, and wherein verifyingthat the at least one operating parameter is within a specifiedoperating metric comprises comparing using a processor at thecertification application the received at least one operating parameterto the specified operating metric.
 5. The method of claim 1, whereincommunicating the certification information comprises receiving the atleast one operating parameter at the certification application, andwherein verifying that the at least one operating parameter is within aspecified operating metric comprises comparing the received at least oneoperating parameter to the specified operating metric.
 6. The method ofclaim 1, wherein verifying that the at least one operating parameter iswithin a specified operating metric comprises comparing using aprocessor in the pump, the at least one operating parameter to thespecified operating metric, and wherein communicating the certificationinformation comprises transmitting a verification to the certificationapplication that the compared at least one operating parameter is withinthe specified operating metric.
 7. The method of claim 1, furthercomprising making a certification determination whether the at least oneoperating parameter is within the received specified operating metricand storing the certification determination in a memory of the pump. 8.The method of claim 7, further comprising transmitting the certificationdetermination from the pump to the remote certification application. 9.The method of claim 1, wherein verifying that the at least one operatingparameter is within a specified operating metric comprises receiving amanual certification instruction to determine the at least one operatingparameter, the manual certification instruction comprising at least onecertification step performed manually by a person.
 10. The method ofclaim 1, wherein the at least one operating parameter comprises a firstoperating parameter with a first specified operating metric and a secondoperating parameter with a corresponding second specified operatingmetric, the first operating parameter and the second operating parameterbeing different from each other and being selected from the groupconsisting of a status of an ultrasonic sensor in the pump, a status ofa power button in the pump, a status or position of a rotor encoder inthe pump, and a status of an accelerometer in the pump, motor current,and ultrasonic sensor voltage, and wherein verifying that the at leastone operating parameter comprises verifying using a processor at thecertification application that the first operating parameter is withinthe first operating metric, and verifying using a processor in the pumpthat the second operating parameter is within the second operatingmetric.
 11. An enteral feeding pump for use with a nutritional liquidfeeding set to deliver nutritional liquid through the feeding set, theenteral feeding pump comprising: a housing capable of receiving at leasta portion of the feeding set; a pumping device supported by the housingand configured to act on the feeding set to produce fluid flow of thenutritional liquid in the feeding set when the at least a portion of thefeeding set is received by the housing; a processor configured todetermine at least one operating parameter of the enteral feeding pump;a memory for storing the at least one operating parameter; and atransceiver configured for communication of certification informationwith a certification application remote from the enteral feeding pump,the communication of certification information including receiving anoperating metric for the at least one operating parameter from thecertification application remote from the enteral feeding pump andtransmitting the at least one operating parameter to the certificationapplication remote from the enteral feeding pump.
 12. The enteralfeeding pump of claim 11, wherein the processor is configured todetermine plural distinct operating parameters and the memory isconfigured to store said plural distinct operating parameters.
 13. Theenteral feeding pump of claim 11, wherein the transceiver is configuredfor wireless communication with the remote certification application.14. The enteral feeding pump of claim 11, wherein the processor isconfigured to make a certification determination whether the at leastone operating parameter is within an operating metric received from theremote certification application and to store the certificationdetermination in the memory.
 15. The enteral feeding pump of claim 11,wherein the transceiver is configured to transmit the at least oneoperating parameter to the remote certification application forevaluation by the remote certification application against a specifiedoperating metric identified by the remote certification application. 16.The enteral feeding pump of claim 11, wherein the processor isconfigured to send a signal recommending performing certification oneach of the at least one operating parameter if the processor evaluatesthat at least one operating parameter is outside of an operating metricspecified by the remote certification application.
 17. The enteralfeeding pump of claim 11, wherein the processor is configured todetermine the at least one operating parameter and the memory isconfigured to store the at least one operating parameter duringoperation of the enteral feeding pump to supply the nutritional liquidto a patient.
 18. An enteral feeding pump certification systemcomprising: an enteral feeding pump for use with a nutritional liquidfeeding set to deliver nutritional liquid through the feeding set, theenteral feeding pump including: a processor configured to determine atleast one operating parameter of the enteral feeding pump: atransceiver; and a certification application remote from the enteralfeeding pump and configured for communication with the transceiver, thecertification application including a certification applicationprocessor configured to execute a certification operation, thecertification application further comprising a memory for storing atleast one of instructions and information relating to the certificationapplication; wherein one of the pump processor and the certificationapplication processor is configured to compare the at least oneoperating parameter to a specified operating metric indicating that theat least one operating parameter is functioning properly, the memorystoring the specified operating metric; wherein one of the pumpprocessor and the certification application processor is furtherconfigured to verify that the at least one operating parameter is withinthe specified operating metric.
 19. The certification system of claim18, wherein the certification application comprises a user interface fordisplaying information relating to the certification application andallowing user interaction with the certification application.
 20. Thecertification system of claim 18, wherein the certification applicationcomprises instructions to identify the specified operating metric. 21.The certification system of claim 18, wherein the specified operatingmetric is associated with electronics of the enteral feeding pump.